The present invention relates to an edible, baked composition which will help control endogenous terol levels when ingested. More specifically, the composition contains cholestyramine which is useful in the control of cholesterol or lipid levels of the blood.
Hypercholesteremia, which is also known as high blood cholesterol level, is believed to be responsible in many cases for atherosclerosis. Therefore, it is exceedingly desirable to effect a reduction of the blood cholesterol level in adult, atherosclerotic patients. This has been done heretofore primarily through the use of low fat diets and medications. However, in many patients this is not sufficient to maintain the cholesterol within the desired limits. Accordingly, it is desirable to administer to the patient a cholesterol lowering agent.
Cholesterol and/or lipid reducing agents are useful in the treatment of arterial plaque formation (i.e. atherosclerosis). These medicinal agents, however, must be administered on a regular, periodic basis in order to exhibit their beneficial effects. Moreover, when formulated as tablet, capsule or liquid dosages, these medicaments have the appearance and character of medicines used in the treatment of sickness and disease. Consequently, patients for whom cholesterol or lipid reducing agents have been prescribed will have an aversion toward routine, daily ingestion of such medicaments.
In particular, cholestyramine is a medicament of choice for the control of cholesterol or lipid levels in humans. Its administration, however, has proved to be problematic from a pharmaceutical compounding point of view. Not only does the cholestyramine exhibit an unpleasant taste and gritty oral consistency, but it is difficult to ingest and/or swallow under most conditions and methods employed to form masking pharmaceutical formulations.
Several attempts have been reported in the literature which attempt to circumvent these difficulties. For example, in EP86-300236, an ingestible anhydrous aggregate comprising starch, a non-cellulosic polysaccharide and cholestyramine is described. This aggregate is a candy which by reason of its extreme sweetness masks the unpleasant taste of the medicament involved. Another example, U.S. Pat. No. 3,974,272, also discloses an oral formulation containing cholestyramine. In this instance, the formulation has a base of milk or fruit juice and contains a hydrophilic colloid which masks the cholestyramine until it has passed the taste receptors along the human alimentary canal.
The sweetness and refined character of such candy confections containing medicaments like cholestyramine are not desirable for an edible medicament composition. The refined ingredients present do not deliver appropriate bulking character to the gut. These disadvantages detract or may, in certain instances, negate the advantage provided by the control of cholesterol level in the blood by cholestyramine.
It would be advantageous to develop a food product for administration of cholestyramine which also contains non-nutritive bulking agents. It would seem that such a food product could be adapted from so-called baked compositions. These baked compositions, however, require the use of high temperatures for congealing and solidifying their ingredients. The high temperature necessary for the baking in such instances will cause decomposition and degradation of cholestyramine. As a result, baked compositions of such ingredients as flour and solid sugars have not been useful as vehicles for the oral administration of cholesterol and lipid control agents such as cholestyramine.
It is an object of the invention, therefore, to develop a baked composition containing cholestyramine which can be prepared at temperatures low enough to avoid or substantially eliminate the degradation and decomposition of cholestyramine. It is another object of the invention to develop a baked composition which is pleasant tasting, has a desirable oral constituency and which masks the unpleasant taste of cholestyramine. It is a further object of the invention to develop a baked composition which will deliver cholestyramine in a form that will enable efficient finding of bile salts and other cholesterol and lipid components present in the gut. Yet another object of the invention is to develop a medicinal formulation which will deliver a level of cholestyramine that will control cholesterol and lipid levels in humans.